The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Supracondylar Intramedullary Nail.
| Device ID | K962561 |
| 510k Number | K962561 |
| Device Name: | SUPRACONDYLAR INTRAMEDULLARY NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Lynette Whittaker |
| Correspondent | Lynette Whittaker ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1996-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024043824 | K962561 | 000 |
| 00889024042780 | K962561 | 000 |
| 00889024042865 | K962561 | 000 |
| 00889024042940 | K962561 | 000 |
| 00889024043022 | K962561 | 000 |
| 00889024043107 | K962561 | 000 |
| 00889024043183 | K962561 | 000 |
| 00889024043268 | K962561 | 000 |
| 00889024043343 | K962561 | 000 |
| 00889024043428 | K962561 | 000 |
| 00889024043503 | K962561 | 000 |
| 00889024043589 | K962561 | 000 |
| 00889024043664 | K962561 | 000 |
| 00889024043749 | K962561 | 000 |
| 00889024042704 | K962561 | 000 |